UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035328 |
|---|---|
| Receipt number | R000040201 |
| Scientific Title | A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis |
| Date of disclosure of the study information | 2018/12/20 |
| Last modified on | 2019/12/27 16:15:51 |
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Basic information
Public title
A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis
Acronym
A multicenter retrospective study on descending necrotizing mediastinitis
Scientific Title
A multicenter retrospective study on the treatment and the prognosis of descending necrotizing mediastinitis
Scientific Title:Acronym
A multicenter retrospective study on descending necrotizing mediastinitis
Region
| Japan |
Condition
Condition
Descending necrotizing mediastinitis
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Chest surgery |
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey on the clinical practice of descending necrotizing mediastinitis in Japan
Basic objectives2
Others
Basic objectives -Others
evaluation of the postoperative outcomes
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative 30-day mortality
Key secondary outcomes
postoperative 90-day mortality, 1-year survival rate, duration of mechanichal ventilation, postoperative hospital stay.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Descending necrotizing mediastinitis treated in JBES/JACS hospitals from January 2012 to December 2016.
Key exclusion criteria
Patients who refused to participate in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenji, Yoshimasa |
| Middle name | |
| Last name | Sugio, Maniwa |
Organization
Oita University
Kobe University
Division name
Department of Thoracic and Breast Surgery
Zip code
879-5593
Address
1-1, Idaigaoka, Hasama-cho, Yufu-shi Oita 879-5593, Japan
TEL
097-586-5854
geka2@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Okamoto |
Organization
Oita University
Division name
Department of Thoracic and Breast Surgery
Zip code
879-5593
Address
1-1, Idaigaoka, Hasama-cho, Yufu-shi Oita 879-5593, Japan
TEL
097-586-5854
Homepage URL
jbes1703-jacs1806@oita-u.ac.jp
Sponsor or person
Institute
Oita University, Department of Thoracic and Breast Surgery
Institute
Department
Personal name
Funding Source
Organization
The Japan Broncho-eshophagological Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe University, Department of General Thoracic Surgery
Name of secondary funder(s)
The Japanese Association for Chest Surgery
IRB Contact (For public release)
Organization
The institutional review boards of Oita University
Address
1-1, Idaigaoka, Hasama-cho, Yufu-shi, Oita 879-5593, Japan
Tel
097-586-5125
rinrikenkyu@oita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational study using a questionnair form
Management information
Registered date
| 2018 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040201
